A Trial to Assess the Effect of Transfusion Strategies on Fatigability Levels After Hospital Discharge

NCT04920045 | Terminated DMC

• 1 other identifier: IRB21-0854
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial in which hospitalized patients with anemia are randomized to receive transfusion at: a) Hb\<9g/dL (liberal transfusion strategy), or b) Hb\<7g/dL (restrictive transfusion strategy). We are measuring self-reported fatigability, fatigue, and activity levels at randomization and 7 days post hospital discharge in both trial arms. In a subset of 75 patients in each trial arm (150 total), we will are administering the 6 Minute Walk Test at randomization and 7 days post discharge.

Conditions

Anemia; Red Blood Cell Transfusion; Fatigability; Fatigue; Physical Function

Outcome Measures

Primary Outcomes (1)

• Change in self-reported fatigability level

  Self-reported fatigability will be measured by the Pittsburgh Fatigability Scale (PFS). The PFS is a 10 item scale that ranges from 0-50 with greater scores indicating greater fatigability.

  Fatigability will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.

Secondary Outcomes (3)

• Change in self-reported fatigue level

  Fatigue will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.

• Change in self-reported activity level

  Activity will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.

• Change in 6 Minute Walk Test (6MWT) distance

  6MWT will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.

Study Arms (2)

Liberal Transfusion Arm

ACTIVE COMPARATOR

Patient's in the liberal transfusion arm will receive a 1 unit RBC transfusion following randomization and will re-ceive blood in additional 1 unit increments until their Hb is above 9g/dL. At any point during the patient's hospital-ization if their Hb subsequently falls below 9g/dL, they will again be transfused to maintain a Hb\>9g/dL, and this will be maintained throughout their hospitalization.

Other: Red blood cell transfusion

Restrictive Transfusion Arm

ACTIVE COMPARATOR

Patients in the restrictive transfusion arm will receive transfusion if their Hb concentration falls below 7g/dL. RBC's will be administered 1 unit at a time and enough blood will be given to increase patient's Hb to above 7g/dL.

Other: Red blood cell transfusion

Interventions

Red blood cell transfusion OTHER

All RBC transfusions will be administered in 1 unit increments to maintain patients' Hb concentration above the trial arm threshold they are randomized to. All transfusions will be followed by a Hb measure and an additional unit(s) of RBC's will only be transfused if there is documentation of the patient's Hb concentration below the trial arm threshold they are randomized to. However, in the case of life-threatening bleeding clinicians will be able to transfuse patients without first checking a patient's Hb concentration. Once randomized, patients will be man-aged according to protocol until hospital discharge independent of transfer to another service and/or specialized hospital ward.

Liberal Transfusion Arm; Restrictive Transfusion Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Hospitalized on a general medicine service at the University of Chicago
• Any hemoglobin (Hb) concentration \<9g/dL

You may not qualify if:

• Have sickle cell anemia
• Decline blood transfusion
• Are receiving palliative care treatment only
• Are brain dead
• Cannot follow up after hospital discharge

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

  PMID: 38780066 DERIVED

MeSH Terms

Conditions

Anemia; Fatigue

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will occur after patients have consented to participate and will be done using permuted block de-sign with random blocks of 2, 4, or 6 patients per block.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 9, 2021
• Study Start: February 1, 2022
• Primary Completion: July 28, 2023
• Study Completion: March 26, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (1)